Services
It is our dedication to find the right solutions for you.
Assign Group’s team of experienced professionals possess the insight, knowledge, and dedication necessary to help you reach your milestones within agreed timelines and budget. It is our objective to make your study a success.
Our services include:
- Feasibility Studies and Site Assessments
- Protocol writing
- Regulatory consulting & contacts
- Project Coordination and Study Management
- Clinical Monitoring
- Central Laboratory Services (kit assembly, short and long term sample storage)
- Analytical Laboratory Services
- Data Management and Biostatistics
- Integrated EDC-Systems – eCRF
- Pharmacovigilance
- Safety Desk, Coding (MedDRA, WHO-DD, ATC)
- IMP: QP releases, labeling, design, import/export, distribution
- Fully integrated Clinical Study Report
- Design of Clinical Development
- Quality Management
Phase I
The Assign Group uses for it´s Phase I studies several different Phase I units, that are situated either in University hospitals specialised Phase I units or SMOs. According to availability and therapeutic requirements your Phase I units are located in Austria, Germany, Belgium, Hungary.
We have easy access to patients and healthy volunteers, with experience in:
- pharmacokinetics
- bioequivalence & bioavailability
- single & multi dose
- drug-drug & drug-food interaction
- pharmacodynamic (renal, cardiovascular pharmacology)
- particular expertise in pharmacogenetics
The on-site services include study protocol development, study conduct, bio-analytical measurements (HPLC, HPLC-Tandem mass spectrometry) and pharmacokinetic analyses using WINNONLIN as well as population kinetics using NONMEM.
Phase II - IV
The Assign Group has extensive experience in conducting global clinical trials.
In advanced stages of clinical development, it is paramount to have a flexible and reliable partner who responds adequately and timely to the specific requirements of your project.
In order to achieve these objectives, the Assign Group provides you with experienced staff and superior quality services.
We ensure the exchange of information between all participating parties, and organize management and communication plans based on your requirements with regards to frequency and format.
Assign Group supports you to implement:
- development strategies
- recruitment of the necessary amount of eligible patients within your timeframes
- budget and cost control tools
- full regulatory compliance
